Evidence map›Paper›PMID 42823741›Full record

ReviewPhilosophy, ethics, and humanities in medicine : PEHM2026

Beyond correlation and causation: epistemic caution, anomalous findings, and COVID-19 vaccine safety.

Alex S Siebner, Alberto Rubio-Casillas, Mikolaj Raszek, David Cowley, Mark Fabrowski, Marina Piscopo, Carlo Brogna, Vladimir N Uversky, Elrashdy M Redwan, Sylvia N Genova

Abstract readReview
In one paragraph

Review in Philosophy, ethics, and humanities in medicine : PEHM, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Alex S SiebnerInstitute for Tropical Medicine, University of Tübingen, Tübingen, Germany. alex.siebner@medizin.uni-tuebingen.de.ORCID https://orcid.org/0009-0008-7412-8943
Alberto Rubio-CasillasJalisco Health Services, Autlan Regional Hospital, Jalisco, Autlan, 48900, Mexico.ORCID https://orcid.org/0000-0003-2978-5107
Mikolaj RaszekAB T5J 3R8, Merogenomics (Science Content Development and Education), Edmonton, Canada.
David CowleyIndependent Researcher, Nottingham, UK.ORCID https://orcid.org/0009-0008-0109-3495
Mark FabrowskiDepartment of Emergency Medicine, Eastern Road, Royal Sussex County Hospital, Brighton, UK.
Marina PiscopoDepartment of Biology, University of Naples Federico II, Naples, Italy.
Carlo BrognaDepartment of Research, Craniomed Group Facility Srl., Montemiletto, Italy.
Vladimir N UverskyDepartment of Molecular Medicine and USF Health Byrd Alzheimer's Research Institute, University of South Florida, Tampa, USA. vuversky@usf.edu.
Elrashdy M RedwanDepartment of Biological Sciences, King Abdulaziz University, Jeddah, Saudi Arabia.ORCID https://orcid.org/0000-0001-8246-0075
Sylvia N GenovaDepartment of General and Clinical Pathology, Medical University Plovdiv, Plovdiv, Bulgaria.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The COVID-19 pandemic exposed science's adaptive strengths and epistemic limits. In fact, in the pandemic, mRNA vaccines are attributed to have saved millions of lives. The maxim "correlation does not imply causation" is an essential safeguard against premature causal inference. However, its use may become epistemically restrictive when the absence of established causality is treated as sufficient reason not to investigate (severe) vaccine adverse events. This article examines the conditions under which a valid cautionary principle may have contributed to premature epistemic closure. Thomas Kuhn's theory of scientific paradigms is used as one interpretative lens rather than as an empirical explanation of institutional behaviour. We argue that the correlation-causation distinction can shift from a heuristic of caution to an instrument of epistemic conservatism, reinforcing prevailing frameworks and discouraging exploration of anomalies. A published autopsy case report involving multifocal necrotizing encephalitis and myocarditis after BNT162b2 vaccination is examined as an illustrative and hypothesis-generating case, not as representative evidence of systematic institutional conduct. A qualitative approach using Bradford Hill's criteria provides partial, inconclusive evidence of a causal relationship while also exposing the methodological limits of the tool employed. The results of the analysis showed that one of the nine criteria demonstrated support of causality, seven were partially supported, and one did not support causality. The analysis suggests, but does not prove, a causal relationship between the BNT162b2 vaccine and multifocal necrotizing encephalitis. The absence of the nucleocapsid protein does not provide definitive evidence to demonstrate a vaccine origin. Analytical methods are described which can distinguish between the wild-type SARS-CoV-2 spike protein and the recombinant spike protein expressed following mRNA vaccination. The absence of evidence does not mean evidence of absence and we must keep an open mind to this when reviewing such evidence on causality.

Indexed as

CausalityCOVID-19COVID-19 VaccinesBNT162 VaccineHumansBNT162 VaccineCOVID-19 VaccinesBradford Hill considerationsCorrelation-causationCOVID-19 vaccinesScientific paradigmSevere adverse eventsVaccine safety

Identifiers

PMID42823741
PMCPMC13628840

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.